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RAPISCAN Solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Rapiscan 400 microgram solution for injection.

Qualitative and quantitative composition

Each 5 ml vial contains 400 micrograms regadenoson (80 micrograms/ml). For the full list of excipients, see section 6.1.

Pharmaceutical form

Solution for injection. Clear, colourless solution.

Therapeutic indications

This medicinal product is for diagnostic use only. Rapiscan is a selective coronary vasodilator for use in adults as a pharmacological stress agent for: radionuclide myocardial perfusion imaging (MPI) ...

Posology and method of administration

Treatment with Rapiscan is restricted to use in a medical facility where cardiac monitoring and resuscitation equipment are available. Posology The recommended dose is a single injection of 400 micrograms ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Second or third degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning ...

Special warnings and precautions for use

Regadenoson has the potential to cause serious and life-threatening reactions, including those listed below (see also section 4.8). Continuous ECG monitoring should be performed and vital signs should ...

Interaction with other medicinal products and other forms of interaction

Methylxanthines Methylxanthines (e.g., caffeine and theophylline) are non-specific adenosine receptor antagonists and may interfere with the vasodilation activity of regadenoson (see section 5.1). Patients ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of regadenoson in pregnant women. Animal studies on pre- and post-natal development have not been conducted. Fetotoxicity, but not teratogenicity, was ...

Effects on ability to drive and use machines

Regadenoson administration may result in adverse reactions such as dizziness, headache, and dyspnoea (see section 4.8) soon after administration. However, most adverse reactions are mild and transient, ...

Undesirable effects

Summary of the safety profile Adverse reactions in most patients receiving regadenoson in clinical trials were mild, transient (usually resolving within 30 minutes after receiving regadenoson) and required ...

Overdose

In a study of healthy volunteers, symptoms of flushing, dizziness and increased heart rate were assessed as intolerable at regadenoson doses greater than 0.02 mg/kg. Treatment Aminophylline may be used ...

Pharmacodynamic properties

Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations ATC code: C01EB21 Mechanism of action Regadenoson is a low affinity agonist (Ki ≈ 1.3 μM) for the A<sub>2A</sub> adenosine receptor, ...

Pharmacokinetic properties

Absorption Regadenoson is administered by intravenous injection for pharmacologic stress radionuclide MPI. The regadenoson plasma concentration-time profile in healthy volunteers is multi-exponential in ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, genotoxicity, or embryo-fetal development. Signs of maternal ...

List of excipients

Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Propylene glycol Disodium edetate Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 4 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

5 ml solution in a single use Type 1 glass vial with (butyl) rubber stopper and aluminium over-seal. Pack size of 1.

Special precautions for disposal and other handling

This medicinal product should be inspected visually for particulate matter and discolouration prior to administration. Any unused product or waste material should be disposed of in accordance with local ...

Marketing authorization holder

GE Healthcare AS, Nycoveien 1, NO-0485, Oslo, Norway

Marketing authorization number(s)

EU/1/10/643/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 06/09/2010 Date of latest renewal: 24/04/2015

Πηγαίο έγγραφο

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